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The FEATHER 01 02 03 04 (Model: 01) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the face.

FEATHER 01 02 03 04 (Models: 01) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 660nm±10nm, 850nm±10nm wavelengths for the treatment of wrinkles. There is only one power/control key on the device, press and hold it for 1.5s to turn on or off the device. Short press the button to adjust the intensity, the white indicator light means the device is running, the flash quickly indicator light means the device is low on power, the slow flashes indicator light means the device is charging.

Based on the provided FDA 510(k) clearance letter for the FEATHER 01 02 03 04 (Model:01) device, here's a breakdown of the acceptance criteria and the study that proves the device meets them.

It's important to note that the provided document is a 510(k) summary, which generally focuses on substantial equivalence to predicate devices rather than detailed clinical trial results for effectiveness when non-clinical tests are deemed sufficient. For this specific device, the submission explicitly states that "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical testing, not a clinical trial demonstrating efficacy.

Acceptance Criteria and Reported Device Performance

Since no clinical efficacy study was conducted for this 510(k) submission, the "acceptance criteria" primarily relate to safety and performance characteristics that demonstrate substantial equivalence to predicate devices. The performance is assessed through non-clinical testing against recognized standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Performance Testing)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in terms of number of devices tested. For non-clinical performance and safety testing against standards (e.g., IEC 60601 series), usually a sample of devices is tested to demonstrate consistent performance and compliance. The document does not provide specific numbers of units tested.
   • Data Provenance: The testing appears to be conducted by the manufacturer or a third-party testing facility, as indicated by compliance reports against international standards (IEC).
   • Retrospective or Prospective: This type of non-clinical testing is inherently prospective, as it involves newly manufactured devices undergoing specific tests to demonstrate compliance.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable in the typical sense for this submission. Ground truth for non-clinical performance testing is established by compliance with objective, measurable engineering and safety standards (e.g., electrical parameters, light output, battery performance). These are verified by accredited testing labs or qualified in-house engineers, not typically "experts" in the clinical interpretation sense.

3. Adjudication Method for the Test Set:

   • Not applicable. Results are based on objective measurements against predefined thresholds specified in the engineering and safety standards. There's no subjective interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." Therefore, no MRMC study, AI assistance, or human reader improvement data is presented.

5. Standalone (Algorithm Only) Performance:

   • This is not an AI/algorithm-driven diagnostic or treatment device in the context of typical standalone performance studies. It is a light-emitting medical device. The "software" mentioned is for device operation (e.g., power control, intensity adjustment), and its validation ensures the proper functioning of the device, not an algorithm's performance in interpreting data or making clinical decisions.

6. Type of Ground Truth Used:

   • For safety and performance testing, the "ground truth" is defined by the requirements of the international consensus standards (e.g., IEC 60601-1, IEC 62471, IEC 62133-2) and the specifications of the predicate devices. The device is deemed "effective" (in the context of a 510(k) for this type of device) if it meets these safety and performance benchmarks and is substantially equivalent to legally marketed devices for its intended use. There is no pathology or outcomes data presented from a clinical study.

7. Sample Size for the Training Set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set" of data for algorithm development. The testing described is for hardware and embedded software compliance.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.

Palm NRG cellulite body device (model: Palm NRG body device) is a portable, non-invasive, at home skin care device. It works for with radio frequency (RF) to help users to enjoy the care skin. The device is a noninvasive, non-ablative device and it is supplied as non-sterile, it has 2 buttons, one for power on/off, the other one for level adjust. The main unit is equipped with accessories of an adapter and a charging base. The charging base is used to connect the adapter and the main unit.

The provided text is a 510(k) summary for a medical device (Palm NRG cellulite body device) and does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or effectiveness.

This document focuses on establishing substantial equivalence to predicate devices based on non-clinical tests and technological characteristics. There is an explicit statement: "There no Clinical Tests."

Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance or a study proving it, as such information is not present in the provided text.

However, I can extract information about the non-clinical tests performed to demonstrate safety and performance:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no clinical performance acceptance criteria or results reported for this device, a table for clinical performance cannot be created. The document focuses on compliance with recognized standards for safety and non-clinical performance:

2. Sample size used for the test set and the data provenance:

• Non-clinical tests: The document does not specify sample sizes for the non-clinical tests (electrical safety, EMC, biocompatibility, software V&V). These tests are typically performed on a representative number of devices to demonstrate design conformity, rather than statistical samples like a clinical trial.
• Usability Study: The sample size for the usability study is not explicitly stated.
• Data Provenance: The tests were performed as part of the submission process to the FDA, likely by accredited labs. The country of origin of the data is not specified beyond the sponsor's affiliations in China and the USA. All tests were prospective for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Non-clinical tests: Not applicable in the context of establishing ground truth for performance. These tests evaluate adherence to engineering and safety standards, often performed by qualified engineers and technicians.
• Usability Study: The document does not specify the number or qualifications of experts involved in establishing ground truth for the usability study. Usability studies typically involve a representative user group rather than "experts" establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as no clinical test set requiring adjudication of device performance against ground truth was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This device is not an AI-assisted diagnostic or interpretive tool, but rather a physical therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical therapeutic device, not an algorithm, and is intended for over-the-counter human use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• No clinical ground truth was established or used, as no clinical studies were performed. The "ground truth" for the non-clinical tests was established by compliance with the defined voluntary design standards. For the usability study, the ground truth would be the ability of users to safely and effectively operate the device according to its instructions for use.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable.

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Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the blue light is indicated for the treatment of the mild to moderate inflammatory acne.

Looper (Model: ZX-579S) is a hand-held device for over-the-counter aesthetic purposes, it's a multifunctional comprehensive beauty instrument. It's combined with the two kinds of operation functions: SONIC and PHOTON mode.

Sonic mode: The Sonic waves can provide vibrating to facial skin. The device provides 5 vibration intensities for users to choose from.

Photon mode: The red light is intended for use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne. It emits energy in the red spectrum for the treatment of facial wrinkles. The therapeutic probe is designed for direct contact with the face for treatment.

The Looper device consists of an applicator and charging base. An applicator is a hand-held unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The charging base charging for the applicator. And there is no external data connection capability (e.g., through USB, Ethernet, WiFi, Bluetooth, etc.) for the device.

There are two keys: the PHOTON key and the SONIC key. The PHOTON is to select red light and the Sonic is to select the SONIC mode and adjust the sonic. Both keys can turn on/off the device.

The provided text describes the 510(k) summary for the "Looper (Model: ZX-579S)" device, which is an over-the-counter powered light-based device for aesthetic purposes, specifically for treating wrinkles and mild to moderate inflammatory acne.

Based on the document, this is a substantially equivalent (SE) determination based on comparison to predicate devices and adherence to relevant safety and performance standards. It is not a study that proves the device meets specific performance acceptance criteria based on clinical outcomes or AI model performance. The document emphasizes compliance with safety and performance standards (like IEC 60601 series) rather than clinical efficacy studies with predefined acceptance criteria. Therefore, most of the requested information regarding AI model performance, clinical study design, and ground truth establishment is not available in this document.

This device is a physical light-based therapy device, not an AI/ML-based diagnostic or assistive device. Thus, questions related to AI model performance, test sets, training sets, expert adjudication, MRMC studies, and AI-specific ground truth are not applicable to this 510(k) submission.

Here's a breakdown of what is provided and why other requested information is absent:

Device Performance and Acceptance Criteria (as per this document)

The "acceptance criteria" in this context are primarily related to safety, electrical performance, electromagnetic compatibility (EMC), usability, and biocompatibility, as outlined by the referenced IEC and ISO standards. The "study that proves the device meets the acceptance criteria" refers to lab bench testing against these engineering and safety standards, rather than clinical trials demonstrating efficacy with specific performance metrics.

Table of Acceptance Criteria and Reported Device Performance:

Reasons for Missing Information & Inapplicability:

This document is a 510(k) Pre-market Notification for a physical medical device (light therapy), not an Artificial Intelligence/Machine Learning (AI/ML) enabled device. Therefore, the following requested information is not applicable or not provided in this type of submission:

2. Sample sized used for the test set and the data provenance: Not an AI/ML device. "Test set" refers to engineering verification and validation against standards, not a clinical data set for AI model evaluation. The data provenance is "lab bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device. Ground truth for an AI/ML algorithm (e.g., image annotation) is not relevant here. Ground truth here means compliance with established engineering and medical device safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a physical device's engineering and safety verification.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not an AI/ML device. MRMC studies are for evaluating performance of AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device revolves around objective measurements of light output, electrical safety, ergonomic performance, and adherence to established biocompatibility and usability standards. It's not about clinical outcomes or diagnostic accuracy in the way an AI model would be.
8. The sample size for the training set: Not an AI/ML device.
9. How the ground truth for the training set was established: Not an AI/ML device.

In summary, the 510(k) for the Looper device demonstrates substantial equivalence to predicate devices and compliance with relevant safety and performance standards for light-based medical devices through lab bench testing. It does not involve AI/ML components or associated clinical validation studies that would require the specific data points requested in your prompt.

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The provided document is an FDA 510(k) clearance letter for the "FitRelief TENS&EMS Wireless Device." This document confirms that the device has been found substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the content of this document.

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The Palm TENS is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Palm TENS." This document grants market clearance based on substantial equivalence to a predicate device. It addresses regulatory matters but does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth, as none of that information is present in the provided FDA letter. The letter is a regulatory approval, not a scientific study report.

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